Fluorescence-Guided Surgery for Head and Neck Cancers

Phase 2

Recruiting

Led By Alfred-Marc Iloreta, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of surgery, up to 24 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial allows surgeons to see cancer cells using 5-aminolevulinic acid and specific wavelengths of light, which may help resection of tumors.

Who is the study for?

This trial is for adults aged 18-80 with new or recurrent head and neck cancers, including skull base tumors, who are scheduled for surgery. Participants must have normal organ function, not be pregnant or breastfeeding, agree to use contraception, and have no history of allergic reactions to similar compounds or certain medical conditions like porphyria.

What is being tested?

Surgeons are testing a technique using 5-Aminolevulinic Acid (5-ALA) to better distinguish cancer cells from healthy tissue during surgery. This FDA-approved agent helps visualize the tumor more clearly when exposed to specific light wavelengths.

What are the potential side effects?

While the side effects of 5-ALA in this context aren't detailed here, common ones may include sensitivity to light where the drug was applied. Since it's used preoperatively just for visualization purposes during surgery, systemic side effects might be minimal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of surgery, up to 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of surgery, up to 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of surgery, up to 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PPIX tissue fluorescence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 5-aminolevulinic acid hydrochloride (Gleolan®)Experimental Treatment1 Intervention

Gleolan® is available in colorless glass vials containing 1.5 g 5-aminolevulinic acid hydrochloride (Gleolan®) Gleolan® is administered orally to patients prior to tumor removal by surgery (20 mg/kg BW).

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